Clinical Response and Quality of Life in Patients with Severe Atopic Dermatitis Treated with Dupilumab: A Single-Center Real-Life Experience

Abstract

Dupilumab is an anti-interleukin-4 receptor monoclonal antibody that was recently approved for the treatment of atopic dermatitis (AD). In this single-center retrospective study, clinical baseline data of 117 severe AD patients treated with dupilumab were collected. At baseline and at weeks 4 and 16, disease severity was assessed through the Eczema Area and Severity Index (EASI) and quality of life through the Dermatology Life Quality Index (DLQI) questionnaire, Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), Peak Pruritus Numerical Rating Scale (NRS-itch), and VAS-sleep. Response to dupilumab was defined as animprovement of ≥75% in EASI from baseline (EASI75). At multivariate analysis, AD onset before 18 years [OR, 2.9; 95% CI, 1.2-7.2; p = 0.0207] and absence of hypereosinophilia [OR, 2.24; 95% CI, 1.03-4.86; p = 0.0412] were identified as significant predictive parameters for response to dupilumab in terms of EASI75 at week 4 but not at week 16. Significant reductions in EASI, DLQI, POEM, HADS, NRS-itch, and VAS-sleep were found between week 4 versus baseline (p < 0.0001 for all) and week 16 versus baseline (p < 0.0001 for all). Early AD onset and absence of hypereosinophilia may be suggested as predictive markers of early response to dupilumab. We confirmed the efficacy and safety of this agent along with the improvement of life quality in severe AD patients.

Use of Dupilumab in 543 Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Retrospective Study

“…Our patients also experienced a significant decrease in serum IgE at follow-up, in accordance with previous studies [19,20,24,25,[28][29][30]32], since Dupilumab blocks IL-4 and IL-13 which normally cause an increased IgE production [8]. For our cohort of patients, the eosinophil count did not change significantly between baseline and week 16 of follow-up, in line with previously reported data from clinical trials [9][10][11].…”

“…For our cohort of patients, the eosinophil count did not change significantly between baseline and week 16 of follow-up, in line with previously reported data from clinical trials [9][10][11]. Nevertheless, in the SOLO1 and SOLO2 trials and in the CAFE trial, dupilumab-treated patients had a greater mean initial increase from baseline in the eosinophil count compared to subjects treated with a placebo, then showing subsequent decreases toward or below baseline levels by week 16 [9,10].The findings of these studies differed from those in two other real-life studies, in which the proportions of dupilumab-treated patients who had eosinophilia within six months of follow-up (57%) or within 16 weeks of follow-up (43%) were significantly higher than the proportions at baseline (33%) and (31%), respectively [19][20][21][22][23][24][25][26][27][28][29].The increase in blood eosinophil counts is consistent with the hypothesis that dupilumab blocks the migration of eosinophils into tissue by inhibiting IL-4-and IL-13-mediated production of eotaxins (as suggested by a reduction in the serum eotaxin-3 level) and vascular-cell adhesion molecule-1 but not eosinophil production or egress from bone marrow [14]. This action results in a transient increase in circulating eosinophil counts.…”

“…Dupilumab has been demonstrated to be an effective treatment for patients with moderateto-severe AD in clinical trials [9][10][11] and in real-life studies [2,[19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]. To date, there have been some reports on real-world experience with dupilumab, including six multicenter studies [14,19,[22][23][24]26].…”

“…As regards the safety of dupilumab, new onset conjunctivitis was observed in 66 patients (12.2%). The reported incidence in clinical trials [9][10][11]and in real-life studies [2,[19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]39]ranges from 5% to 28%, and from 6% to 62% of dupilumab-treated patients, respectively. During the clinical development of dupilumab in AD [40], the incidence of conjunctivitis was around 10% and infrequent in patients with asthma or nasal polyposis, suggesting that some characteristics of patients with AD may contribute to cause this, as eye involvement can be a comorbidity in AD [41].…”

Adipokines as Biomarkers of Atopic Dermatitis in Adults

“…Nonetheless, some of them, like IL-2, have an identifiable itch-enhancing effect [15]. Highly effective biological therapy with dupilumab, a monoclonal antibody that binds to IL-4 and IL-13 receptors, substantiates the role of interleukins in the development of AD symptoms [16].…”